Risk Factors for Postoperative Complications in Surgery With Pneumoperitoneum in Trendelenburg Position. Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Perioperative change in urine NGAL
研究概览
简要总结
Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Class I-IV.
- •Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.
- •Planned arterial catheter insertion.
排除标准
- •Pregnancy.
- •Planned open abdominal surgery.
- •Renal Replacement Therapy.
结局指标
主要结局
Perioperative change in urine NGAL
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Acute Kidney Injury
时间窗: 2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.
According to the KDIGO acute renal injury stage
Perioperative change in serum NGAL
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample
Perioperatitve change in serum concentration of Cannabidiol
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample
Perioperatitve change in urine concentration of Cannabidiol
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Perioperatitve change in TBW
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperative change in the bioimpedence-based measurement of Total Body Water (TBW)
Perioperatitve change in ECW
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperative change in the bioimpedence-based measurement of Extracellular Water (ECW)
Perioperatitve change in serum pH
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
As measured by arterial blood gas
Perioperatitve change in serum BE
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum Base Excess (BE) As measured by arterial blood gas
Perioperatitve change in serum lactate concentration
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Perioperatitve change in serum lactate concentration as measured by arterial blood gas
Perioperatitve change in serum syndecan-1 concentration
时间窗: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Measured by ELISA
次要结局
- Delirium(Within 7 days after surgery)
- CVA / TIA(Within 30 days after surgery)
- Myocardial Ischemia(During hospital stay, within 30 days after surgery)
- Arrhythmia(During hospital stay, within 30 days after surgery)
- Atelectasis(During hospital stay, within 30 days after surgery)
- Pneumonia(During hospital stay, within 30 days after surgery)
- ARDS(During hospital stay, within 30 days after surgery)
研究者
Reuven Pizov
Anesthesia Department Chair
Hadassah Medical Organization